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Trimetazidine hydrochloride sustained-release pellet and preparation method thereof

A technology of trimetazidine hydrochloride and sustained-release pellets, which is applied in the field of medicine, can solve the problems of poor sustained-release effect and short sustained-release time, and achieve scientific and reasonable formula and structure, low irritation and good fluidity Effect

Inactive Publication Date: 2019-09-17
湖北欣泽霏药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The examples of the present application provide a kind of trimetazidine hydrochloride sustained-release pellets and a preparation method thereof, which solve the problems of short sustained-release time and poor sustained-release effect of the existing trimetazidine hydrochloride sustained-release preparations, and realize hydrochloric acid Long-acting sustained-release of trimetazidine sustained-release preparations, and reached the zero-order release standard

Method used

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Examples

Experimental program
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preparation example Construction

[0045] The embodiment of the application also provides a preparation method of the aforementioned trimetazidine hydrochloride sustained-release pellets, which includes the following steps:

[0046] Preparing trimetazidine hydrochloride, binders and fillers into a medicinal solution in proportion, and then spray drying or fluidized bed granulation to obtain composite pellet cores;

[0047] The plasticizer, retarder and anticoagulant are prepared into a coating liquid in proportions, and then the composite pellet core is sequentially fluidized bed coating and dried to obtain trimetazidine hydrochloride sustained-release pellets.

[0048] In the embodiments of the application, preferably, the solvents used for preparing the above-mentioned medicinal solution and coating solution are selected from one or more of water, ethanol, isopropanol and acetone. These solvents are used to dissolve trimetazidine, adhesives and fillers or plasticizers, retarders and anticoagulants to make trimetazid...

Embodiment 1

[0060] In this example, trimetazidine hydrochloride sustained-release pellets were prepared according to the following formula and preparation method: trimetazidine hydrochloride 80g, sucrose 20g, hypromellose 4.0g, acetyl tributyl citrate 0.8g, ethyl fiber Vegetarian 10g, talc 18g.

[0061] The preparation process of the trimetazidine hydrochloride sustained-release pellets of this embodiment is: dissolving and diluting the trimetazidine hydrochloride, sucrose and hypromellose with water, spray drying, and sieving to obtain pellets with a diameter of 200-2000 μm The pellets are used as composite pellet cores. The above-mentioned acetyl tributyl citrate, ethyl cellulose and talc are prepared into a coating liquid with water, and then the composite pellet core is sequentially fluidized bed coating and dried, and pellets with a particle size of 200-2000 μm are screened out. It is trimetazidine hydrochloride sustained-release pellets.

Embodiment 2

[0063] In this example, trimetazidine hydrochloride sustained-release pellets were prepared according to the following formula and preparation method: trimetazidine hydrochloride 80g; microcrystalline cellulose 60g; hydroxypropylcellulose 20g; polyethylene glycol 1.6g; cellulose acetate 16g ; Talc 8g.

[0064] The preparation process of the trimetazidine hydrochloride sustained-release pellets of this embodiment is: dissolving and diluting the trimetazidine hydrochloride, microcrystalline cellulose and hydroxypropyl cellulose with water, granulating in a fluidized bed, and sieving the pellets obtained The pellets with a diameter of 200-2000μm are used as composite pellet cores. The above polyethylene glycol, cellulose acetate and talc are prepared into a coating liquid with water, and then the composite pellet core is sequentially fluidized bed coating and dried, and pellets with a particle size of 200-2000μm are screened out, which is hydrochloric acid Trimetazidine sustained-r...

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Abstract

The invention discloses a trimetazidine hydrochloride sustained-release pellet and a preparation method thereof, and relates to the technical field of medicine. The trimetazidine hydrochloride sustained-release pellet is composed of a composite pellet core and a sustained-release coating layer, wherein the composite pellet core is prepared from, by weight, 200 parts of trimetazidine hydrochloride, 20-200 parts of a filler and 10-50 parts of an adhesive; the sustained-release coating layer is prepared from, by weight, 2-5 parts of a plasticizer, 10-40 parts of a retarder and 5-50 parts of an anticoagulant. The trimetazidine hydrochloride sustained-release pellet solves the problems of short sustained-release time and poor sustained-release effect of an existing trimetazidine hydrochloride sustained-release preparation, achieves the long-acting sustained release of the trimetazidine hydrochloride sustained-release preparation, and achieves the standard of zero-order release.

Description

Technical field [0001] The application relates to the technical field of medicine, and in particular to a trimetazidine hydrochloride sustained-release pellet and a preparation method thereof. Background technique [0002] Trimetazidine (TMZ), whose chemical name is 1-(2,3,4-trimethoxybenzyl)piperazine, is the first 3-ketoacyl-CoA thiolase inhibitor (3-KAT ), is a commonly used anti-angina pectoris drug in clinical practice. It can inhibit the oxidation of fatty acids (FFA), stimulate the oxidation of glucose, and to a certain extent has a protective effect against myocardial ischemic cells. At present, trimetazidine hydrochloride preparations have been widely used clinically in the preventive treatment of angina pectoris and auxiliary symptomatic treatment of dizziness and tinnitus. It has the advantages of significant curative effect, can be combined with other drugs, and has fewer adverse reactions. [0003] Trimetazidine is absorbed rapidly after oral administration, with a r...

Claims

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Application Information

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IPC IPC(8): A61K9/52A61K31/495A61P9/10
CPCA61K9/501A61K9/5042A61K31/495A61P9/10
Inventor 李永进其他发明人请求不公开姓名
Owner 湖北欣泽霏药业有限公司
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